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In a clinical study of healthy adults, Dyanavel XR tablets were deemed to be bioequivalent to amphetamine extended-release oral suspension in patients with attention-deficit/hyperactivity disorder (ADHD) by the US Food and Drug Administration (FDA).
The US Food and Drug Administration has approved amphetamine (Dyanavel XR, Tris Pharma) extended-release once daily tablet, for the treatment of individuals 6 years of age or older with attention-deficit/hyperactivity disorder (ADHD).
"The approval of Dyanavel XR tablets, which use Tris' LiquiXR technology platform, fills an important gap in Tris' portfolio of ADHD products to fit the needs of a variety of patient types. Dyanavel XR oral suspension and now Dyanavel XR tablets provide a unique pharmacokinetic profile and a broad range of dosing options for patients needing an amphetamine for their ADHD," said James Hackworth, PhD, president of the Tris Pharma Branded Products Division, in a press release.
In a clinical study of healthy adults, Dyanavel XR tablets were deemed to be bioequivalent to amphetamine extended-release oral suspension.
The oral suspension demonstrated improvements of ADHD symptoms in children 6 to 12 years of age within an hour and lasted through 13 hours after once-daily dosing, according to Tris Pharma. In another study, the amphetamine oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing.
In a separate study, Dyanavel XR tablets demonstrated statistically significant improvements compared to placebo in mean Permanent Product Measure of Performance Total.
The most common adverse events were insomnia, dry mouth, headache, irritability, nausea, and dizziness.
Dyanavel XR tablets are expected to be available in pharmacies in the first quarter of 2022.
Tris Pharma announces FDA approval of DYANAVEL XR (amphetamine) once-daily extended-release oral tablets, CII, for ADHD. Email. News release. November 5, 2021. Accessed November 5, 2021.